AdvanCell Isotopes ²¹²Pb Generator

Lead-212 possesses a half-life of 10.6 hours. Current production methodologies severely impact the availability of radionuclide therapy (i.e. isotope generation, QC, radiopharmaceutical compounding, transport + administration within ~5-hours) and limits access to the therapy for patients in need. The challenge was to design + engineer a small footprint generator that could be produced and operated at scale around the state, country + world to serve large patient populations. The generator needed to shield operators from radiation, be intuitive to use and enable reliable production of radio isotopically pure product for an extended period. The goal was to cultivate a design that would encompass all aspects of the electronics + mechanical apparatus that are used to automate the novel production of the high-value isotope (Lead-212). The generator would be required to run continuously for 24-hours to produce clinical doses.

The Isotope Generator enables the scaled production of isotopes, enabling clinical trials and treatments that had previously been restricted. A focus on quality, reliability and traceability and a goal of a GMP product will provide clinicians with access to mission critical medicines when needed, and not only when and if available. The Generator is currently producing clinically useful amounts of Lead-212 daily and is being used by researchers in Australia, with a clinical trial scheduled for 4Q 2022. The Generator is a platform technology that enables the development of a number of Targeted Alpha Therapies for different cancers. + Ergonomically optimised for the safe use of operators within space and time constrained conditions behind protective lead shielding + Bench-sized mechanically compact + portable isotope generation device + Several complex sub-assemblies intro a volume production solution (DFM) + Intuitive for serviceability: easily interchangeable vacuum pump assembly

The Isotope Generator can easily scale production by increasing the source capacity and/or running generators in parallel. Redundancy of production is supported. AdvanCell have reported that Targeted Alpha Therapies have proven clinical benefits when used in the treatment of prostate and neuroendocrine cancers. Due to Lead-212’s short half-life, transporting, storing and administering the isotope is time sensitive. The Isotope Generator will save countless hours and lives by eliminating the challenges associated with long-haul transportation and storage. Scalable production of these rare alpha emitting isotopes and turning them into therapies for a broad range of cancers enables greater access to treatments for patients who need it most.

+ Modularity of process design means that more parent isotope containers can be added in future revisions to easily increase production of Lead-212. + Wireless connectivity to external UI reduces radiation exposure to operators. + Local clinic production can be performed unsupervised through a completely automated process reducing the risk of radiation exposure to operators, and reduces the potential of generating wasted doses. + External UI offers Researchers the ability to make adjustments to isotope elution parameters. + Advanced error detection and logging of system states means system faults can be identified and remedied early, and provides confidence and traceability for treatment doses of Lead-212. Materials: + Customised internal steam delivery system; no metal; combination of silicon carbide and PTFE pressure vessels. + Combination of tungsten shielding and 316 stainless steel construction to shield radiation / protect sensitive electronic control systems and maintain product safety. + All gas and fluid delivery designed using high-end PVDF and silicon for fittings and components.